Item 2.02 Results of Operations and
Financial Condition.
As discussed below, in
connection with its participation in the 39th Annual J.P. Morgan
Healthcare Conference on January 14th, 2021, Agile Therapeutics,
Inc. (the “Company”) updated its corporate presentation to include
disclosure that the Company had an estimated $54.5 million of cash
and cash equivalents on hand as of December 31, 2020. In the
presentation, the Company also reaffirms its projections that,
based on the Company’s current business plan and the launch of
Twirla, its current cash, cash equivalents and marketable
securities will be sufficient to meet its projected operating
requirements through the end of 2021 and that it expects its gross
revenue will be approximately $1 million, reflecting expectations
of initial stocking of Twirla by wholesalers.
Because the Company’s financial statements for the year ended
December 31, 2020 have not yet been finalized or audited, this
preliminary statement regarding the Company’s cash and cash
equivalents as of December 31, 2020 is subject to change, and the
Company’s actual cash and cash equivalents on hand as of the end of
this period may differ materially from this preliminary estimate.
Accordingly, you should not place undue reliance on this
preliminary estimate.
Item 7.01. Regulation FD
Disclosure.
The information set forth in Item
2.02 of this Current Report on Form 8-K (this “Report”) is
incorporated into this Item 7.01 by reference.
The Company will participate in
the 39th Annual J.P. Morgan Healthcare Conference in San Francisco,
California, which is being held virtually, on Thursday, January 14,
2021 at 9:10 a.m. Eastern Time, and has updated the corporate
presentation that it intends to use at the conference. The Company
may use this updated corporate presentation in meetings with
investors from time to time as well. In addition to the
above-referenced disclosure regarding the Company’s cash and cash
equivalents as of December 31, 2020, the updates primarily involve
financial projections on cash runway and gross revenue, and the
Company’s commercialization of Twirla® (levonorgestrel and ethinyl
estradiol) transdermal system, its first FDA-approved
product.
A copy of the Company’s updated corporate presentation is attached
hereto as Exhibit 99.1 and is hereby incorporated by reference
herein.
In accordance with General
Instructions B.2 and B.6 of Form 8-K, the information included in
Item 2.02 and Item 7.01 of this Report shall not be deemed “filed”
for the purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by
reference into any filing made by the Company under the Exchange
Act or the Securities Act of 1933, as amended, except as shall be
expressly set forth by specific reference in such a
filing.
Forward-Looking Statements
Certain
information contained in this Report may include “forward-looking
statements.” Our use of terms such as “predicts,” “believes,”
“potential,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes
may identify these forward-looking statements.
In particular, statements regarding
our projected cash position and gross revenue are examples of such
forward-looking statements. Such forward-looking statements are
subject to important risks and uncertainties, including, but not
limited to, risks related to our ability to maintain regulatory
approval of Twirla, the ability of our third party manufacturer,
Corium, to produce commercial supply in quantities and quality
sufficient to satisfy market demand for Twirla, our ability to
successfully commercialize and obtain market access for Twirla, the
successful development of our sales and marketing capabilities, the
accuracy of our estimates of the potential market for Twirla, our
ability to achieve our target formulary access goals, regulatory
and legislative developments in the United States and foreign
countries, our ability to obtain and maintain intellectual property
protection for Twirla, our strategy, business plans and focus, the
effects of the COVID-19 pandemic on our operations and the
operations of third parties we rely on as well as on our potential
customer base, unforeseen market factors or events in our
clinical,
